8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C.  20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

Date of report (Date of earliest event reported)   January 9, 2006

Cephalon, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware	0-19119	23-2484489
(State or Other Jurisdiction	(Commission	(IRS Employer
of Incorporation)	File Number)	Identification No.)
41 Moores Road
Frazer, Pennsylvania		19355
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code   (610) 344-0200

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 1.01Entry into a Material Definitive Agreement.

On January 9, 2006, Cephalon, Inc. (“Cephalon” or the “Registrant”) entered into an agreement with Mylan Pharmaceuticals Inc. (“Mylan”) to settle its pending patent infringement dispute in the United States (the “Agreement”) related to PROVIGIL® (modafinil) Tablets [C-IV] (“PROVIGL”).

In connection with the Agreement, the Reigstrant will grant Mylan a non-exclusive royalty-bearing right to market and sell a generic version of PROVIGIL in the United States.  Mylan’s license will become effective in October 2011 unless Cephalon obtains a pediatric extension for PROVIGIL, which would permit entry by Mylan in April 2012.  An earlier entry by Mylan may occur based upon the entry of another generic version of PROVIGIL.

The Registrant and Mylan will promptly file a dismissal with prejudice with the United States District Court for the District of New Jersey that will conclude all pending litigation between the Registrant and Mylan regarding PROVIGIL.  This Agreement and the previously announced agreements with Teva Pharmaceutical Industries Ltd. and its affiliate and Ranbaxy Laboratories Limited do not affect the status of the ongoing PROVIGIL patent litigations between the Registrant and certain other generic companies that are pending in the U.S. District Court in New Jersey.  These lawsuits claim infringement of the Registrant’s U.S. Patent No. RE37,516 (“the ‘516 Patent”) which covers pharmaceutical compositions and methods of treatment with the form of modafinil contained in PROVIGIL.  The ‘516 patent expires in October 6, 2014 and may be extended by six months (to April 6, 2015) upon submission of pediatric study data that is acceptable to the U.S. Food and Drug Administration.

The above description of the terms between the Registrant and Mylan is not intended to be a complete summary of all of the terms and conditions of the Agreement.  Many of the terms and conditions of the Agreement remain confidential.  There can be no assurance that the Federal Trade Commission will not raise objections to, or request modifications to, the Agreement; that any such modifications will be acceptable to the Registrant and Ranbaxy; or that the Agreement will become effective on the terms currently proposed or at all.

The Registrant hereby incorporates by reference the press release dated January 10, 2006, attached hereto as Exhibit 99.1, and made a part of this Item 1.01.

Item 8.01Other Events.

(a)On January 9, 2006, Cephalon and Mylan Laboratories Inc. also entered into two product development collaboration agreements under which the companies will explore utilizing Mylan Technologies Inc.’s transdermal technology to address pain and certain central nervous system disorders.  Under the arrangements, Cephalon will have an option to develop and commercialize the products in exchange for payment of milestones and ongoing royalties based on net sales of the products.

(b)On December 28, 2005, Cephalon publicly announced that it has received a response from the United States Food and Drug Administration (the “FDA”) regarding the New Drug Application (the “NDA”) for VIVITROL® (naltrexone for extended-release injectable suspension) for the treatment of alcohol dependence.  A copy of the press release announcing the FDA’s response is attached hereto as Exhibit 99.2 and incorporated herein by reference.

(c)On December 21, 2005, Cephalon submitted data to the FDA relating to clinical studies of PROVIGIL® (modafinil) in pediatric patients.

Item 9.01Financial Statements and Exhibits.

(a)Financial Statements of Business Acquired.

None

(b)Pro forma Financial Information.

None

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(c)Exhibits.

Exhibit No.	Description of Exhibit
99.1	Press Release dated January 10, 2005 – Cephalon, Inc. Announces Agreement with Mylan Pharmaceuticals Inc. Regarding Settlement of PROVIGIL® Patent Litigation
99.2	Press Release dated December 28, 2005 — FDA Issues Approvable Letter for VIVITROL (Formerly VIVITREX®), for the Treatment of Alcohol Dependence

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	CEPHALON, INC.
Date: January 12, 2006	By:	/s/ John E. Osborn
		John E. Osborn
		Senior Vice President, General Counsel & Secretary

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EXHIBIT INDEX

Exhibit No.	Description of Exhibit
99.1	Press Release dated January 10, 2005 – Cephalon, Inc. Announces Agreement with Mylan Pharmaceuticals Inc. Regarding Settlement of PROVIGIL® Patent Litigation
99.2	Press Release dated December 28, 2005 — FDA Issues Approvable Letter for VIVITROL (Formerly VIVITREX®), for the Treatment of Alcohol Dependence

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EX-99.1

Exhibit 99.1

News

Cephalon Contacts

Media: Robert Grupp

610-738-6402

rgrupp@cephalon.com

Investors: Chip Merritt

610-738-6376

cmerritt@cephalon.com

For immediate release

Cephalon, Inc. Announces Agreement with Mylan Pharmaceuticals Inc.
Regarding Settlement of PROVIGIL® Patent Litigation

Frazer, Pa. – January 10, 2006 – Cephalon, Inc. (Nasdaq: CEPH) announced today that it has entered into an agreement with Mylan Pharmaceuticals Inc. to settle its pending patent infringement dispute in the United States related to PROVIGIL® (modafinil) Tablets [C-IV].

In connection with the settlement, Cephalon will grant Mylan a non-exclusive royalty-bearing right to market and sell a generic version of PROVIGIL in the United States.  Mylan’s license will become effective in October 2011, unless Cephalon obtains a pediatric extension for PROVIGIL which would permit entry by Mylan in April 2012.  An earlier entry by Mylan may occur based upon the entry of another generic version of PROVIGIL.

The terms of the agreement are confidential, and are subject to review by the U.S. Federal Trade Commission. Financial terms were not disclosed.

The parties will promptly file a dismissal with prejudice with the United States District Court for the District of New Jersey that will conclude all pending litigation between the parties regarding PROVIGIL. This settlement and the previously announced settlements with Teva Pharmaceutical Industries Ltd. and its affiliate and Ranbaxy Laboratories Limited do not affect the status of the ongoing PROVIGIL patent litigations between Cephalon and certain other generic companies that are pending in the U.S. District Court in New Jersey. These lawsuits claim infringement of Cephalon’s U.S. Patent No. RE37,516 (“the ‘516 Patent”) which covers pharmaceutical compositions and methods of treatment with the form of modafinil contained in PROVIGIL. The ‘516 patent expires in October 6, 2014 and may be extended by six months (to April 6, 2015) upon submission of pediatric study data that is acceptable to the U.S. Food and Drug Administration.

SOURCE:  Cephalon, Inc. • 41 Moores Road • Frazer, PA  19355 • (610) 344-0200 • Fax (610) 344-0065

Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products to treat sleep and neurological disorders, cancer and pain. Cephalon currently employs approximately 2,500 people in the United States and Europe. U.S. sites include the company’s headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.

The company currently markets four proprietary products in the United States: PROVIGIL, GABITRIL^® (tiagabine hydrochloride), ACTIQ^® (oral transmucosal fentanyl citrate) [C-II] and TRISENOX^® (arsenic trioxide) injection, and more than 20 products internationally. Full prescribing information for all U.S. products is available at www.cephalon.com or by calling
1-800-896-5855.

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In addition to historical facts or statements of current condition, this press release may contain forward-looking statements.  Forward-looking statements provide Cephalon’s current expectations or forecasts of future events.  These may include statements regarding the settlement of this litigation, including whether the Federal Trade Commission will approve the terms of such settlement,  anticipated scientific progress on its research programs; development of potential pharmaceutical products; interpretation of clinical results; prospects for regulatory approval; manufacturing development and capabilities; market prospects for its products; sales and earnings guidance; and other statements regarding matters that are not historical facts.  You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning.  Cephalon’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission.  Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect.  Therefore, you should not rely on any such factors or forward-looking statements.  Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law.  The Private Securities Litigation Reform Act of 1995 permits this discussion.

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EX-99.2

Exhibit 99.2

		News
			Investor Contacts:
			Rebecca Peterson
			617-583-6378
			Alkermes, Inc.
			Chip Merritt
			Cephalon, Inc.
			610-738-6376
			cmerritt@cephalon.com
			Media Contacts:
			Elizabeth Hunter
			Biosector 2
			(212) 845-5610

For Immediate Release

FDA Issues Approvable Letter for VIVITROL™ (Formerly
VIVITREX^®), for the Treatment of Alcohol Dependence

Alkermes and Cephalon Continue to Anticipate Product Launch in Second Quarter 2006

Cambridge, MA, and Frazer, PA, December 28, 2005 — Alkermes, Inc. (Nasdaq: ALKS) and Cephalon, Inc. (Nasdaq: CEPH) today announced that the United States Food and Drug Administration (FDA) issued an approvable letter for VIVITROL^TM (naltrexone for extended-release injectable suspension), which is under review for the treatment of alcohol dependence in combination with a treatment program that includes psychosocial support.  The New Drug Application (NDA) for VIVITROL, formerly known as VIVITREX^®, was submitted on March 31, 2005.  Alkermes and Cephalon continue to prepare for the launch of VIVITROL during the second quarter of 2006.

FDA approval of VIVITROL is contingent upon finalizing the product label and satisfying a request by FDA for preclinical pharmacokinetic data to support reference to existing oral naltrexone preclinical data.  VIVITROL was filed as a 505(b)(2) NDA application, permitting Alkermes to reference results of studies that were previously submitted to the FDA in support of the original oral naltrexone NDA.

“This approvable letter is a positive step toward the approval of VIVITROL,” stated Richard Pops, CEO of Alkermes.  “We look forward to working diligently with the

SOURCE:  Cephalon, Inc. • 41 Moores Road • Frazer, PA 19355 • (610) 344-0200 • Fax (610) 344-0065

FDA to gain final approval and bring forward VIVITROL as an important new medication for the treatment of alcohol dependence.”

“Our plans for the launch of VIVITROL in the second quarter of 2006 are on track,” said Frank Baldino, Jr., Ph.D., Chairman and CEO of Cephalon.  “We are hiring sales representatives and designing education and training programs to ensure that physicians and counselors can identify patients who could benefit the most from the inclusion of this medication in their treatment plan.”

About Alkermes, Inc.

Alkermes, Inc. is a pharmaceutical company that develops products based on sophisticated drug delivery technologies to enhance therapeutic outcomes in major diseases.  The Company’s lead commercial product, RISPERDAL^® CONSTA^® [(risperidone) long-acting injection], is the first and only long-acting atypical antipsychotic medication approved for use in schizophrenia, and is marketed worldwide by Janssen-Cilag (Janssen), a wholly owned division of Johnson & Johnson.  The Company’s lead proprietary product candidate, VIVITROL^TM (naltrexone for extended-release injectable suspension), is being developed as a once-monthly injection for the treatment of alcohol dependence.  The Company has a pipeline of extended-release injectable products and pulmonary drug products based on its proprietary technology and expertise.  Alkermes’ product development strategy is twofold: the Company partners its proprietary technology systems and drug delivery expertise with several of the world’s finest pharmaceutical companies and it also develops novel, proprietary drug candidates for its own account.  The Company’s headquarters are in Cambridge, Massachusetts, and it operates research and manufacturing facilities in Massachusetts and Ohio.

About Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products to treat sleep and neurological disorders, cancer and pain. Cephalon currently employs approximately 2,600 people in the United States and Europe. U.S. sites include the company’s headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.

The company currently markets four proprietary products in the United States: PROVIGIL^® (modafinil) [C-IV], GABITRIL^® (tiagabine hydrochloride), ACTIQ^® (oral transmucosal fentanyl citrate) [C-II] and TRISENOX^® (arsenic trioxide) injection, and more than 20 products internationally. Full prescribing information for all U.S. products is available at www.cephalon.com or by calling 1-800-896-5855.

* * *

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Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements related to attaining final regulatory approval of VIVITROL, which will include labeling discussions with FDA and satisfying a request for preclinical data, the status of launch plans, the timing of the VIVITROL launch, and the ultimate commercial success of VIVITROL.  Although both Cephalon and Alkermes believe that such statements are based on reasonable assumptions within the bounds of their respective knowledge, the forward-looking statements are neither promises nor guarantees, and both the Alkermes and Cephalon businesses are subject to significant risk and uncertainties.  As such, there can be no assurance that either or both of Cephalon’s or Alkermes’ actual results will not differ materially from their respective expectations.  Such expectations are subject to risks, including, among others whether Alkermes can successfully scale up and manufacture VIVITROL at a commercial scale; whether VIVITROL will ultimately receive marketing approval from FDA in a timely fashion or at all, and, if approved, whether it will be launched and commercialized successfully by Alkermes and Cephalon; the outcome of clinical and preclinical work Alkermes and its partners are pursuing, including the results of preclinical pharmacokinetic data; decisions by the FDA regarding VIVITROL, which may be based on interpretations of data that differ from Alkermes’ interpretations; and whether VIVITROL in commercial use, may have unintended side effects, adverse reactions or incidents of misuse that could cause the FDA or other health authorities to require post approval studies or require removal of the product from the market.  For further information with respect to specific risks, uncertainties and factors that could cause actual results to differ from expectations, reference is made to the reports on Forms 8-K, 10-Q and 10-K that Cephalon and Alkermes each filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended.  The forward-looking statements made in this release are made only as of the date hereof and both Cephalon and Alkermes disclaim any intention or responsibility for updating such statements, except as may be required by law.

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